Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
175,820 results
31513–31536 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 28, 2016
AESKUSLIDES ANA HEp-2-Gamma, HELIOS FULLY AUTOMATED IFA SYSTEM
K153117 · DHN
Aesku Systems GmbH&Co.Kg
Immunology · 274d
Cleared Jul 28, 2016
Atteris Antimicrobial Skin & Wound Cleanser
K160192 · FRO
Rochal Industries, LLC
General & Plastic Surgery · 183d
Cleared Jul 28, 2016
Cardinal Health Isolation Gown
K160339 · FYC
Cardinal Health200, LLC
General Hospital · 171d
Cleared Jul 28, 2016
Spinal Elements' Spinous Process Plate System
K160465 · PEK
Spinal Elements, Inc.
Orthopedic · 160d
Cleared CT Jul 28, 2016
Angel Catheter
K160747 · PNS
Bio2 Medical, Inc.
Cardiovascular · 132d
Cleared Jul 28, 2016
PBS(-), Phosphate Buffered Saline
K160863 · MQL
Kitazato Biopharma Co;Ltd
Obstetrics & Gynecology · 121d
Cleared Jul 28, 2016
Elecsys Syphilis
K160910 · LIP
Roche Diagnostics
Microbiology · 118d
Cleared Jul 28, 2016
8ch Foot Ankle Coil
K160935 · MOS
Shenzhen RF Tech Co., Ltd.
Radiology · 115d
Cleared Jul 28, 2016
POLYISOPRENE POWDER FREE SURGICAL UNDERGLOVE, POLYISOPRENE POWDER FREE...
K161008 · KGO
Hartalega Sdn Bhd
General Hospital · 108d
Cleared Jul 28, 2016
XSTAT-12, 3-Pack, XSTAT-12, 1-Pack
K161020 · PGZ
Revmedx, Inc.
General & Plastic Surgery · 107d
Cleared Jul 28, 2016
SIMPLANT Online Case Review and SIMPLANT Editor
K161118 · LLZ
Dentsply Sirona
Radiology · 99d
Cleared Jul 28, 2016
LVivo Software Application
K161382 · LLZ
Diacardio, Ltd.
Radiology · 71d
Cleared CT Jul 28, 2016
3D OCT-1 Maestro
K161509 · OBO
Topcon Corporation
Ophthalmic · 57d
Cleared Jul 28, 2016
MAMMI
K161631 · KPS
General Equipment For Medical Imaging
Radiology · 45d
Cleared Jul 28, 2016
Waterlase Express
K161669 · GEX
Biolase, Inc.
General & Plastic Surgery · 42d
Cleared Jul 28, 2016
Medilas H Laser Fibers
K161771 · GEX
Dornier Medtech America, Inc.
General & Plastic Surgery · 30d
Cleared Jul 28, 2016
ACUSON NX2 Diagnostic Ultrasound Systems
K161787 · IYN
Siemens Medical Solutions USA, Inc.
Radiology · 29d
Cleared Jul 28, 2016
ImmunoCAP Total IgE Calibrator Strip/Total IgE Curve Control Strip, ImmunoCAP...
K161899 · DGC
Phadia AB
Immunology · 17d
Cleared Jul 27, 2016
The Progressive Orthopaedic Total Hip System
K151424 · LPH
The Progressive Orthopaedic Company, LLC
Orthopedic · 426d
Cleared Jul 27, 2016
Zeramex P6 Dental Implant System
K152385 · DZE
Dentalpoint AG
Dental · 338d
Cleared Jul 27, 2016
Tubli-Seal, Tubli-Seal EWT,Tubli-Seal Xpress, Tubli-Seal EWT Xpress
K153067 · KIF
Sybron Dental Specialties
Dental · 279d
Cleared Jul 27, 2016
Dillard Airway Dilatation System
K153484 · KTI
Intuit Medical Products, LLC
Ear, Nose, Throat · 237d
Cleared Jul 27, 2016
SinuBand
K160101 · QJL
Bioinspire Technologies, Incorporated
Ear, Nose, Throat · 190d
Cleared Jul 27, 2016
Nissin Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank
K160367 · EIH
Nissin-Metec China Co., Ltd.
Dental · 169d